For the sake of clarity, the following terms, which shall be used in the present application, are to be defined as follows:
The terms “inlet” and “outlet” as used herein as referring to liquid ports, do not come to limit the use of such a port to a directional flow of the fluid, and in some cases (such as dialysis) the direction can be reversed.
The term “fluid peripheral elements”, as used herein, includes any fluid reservoir that is intended to supply fluid to a patient, such as an infusion bag containing blood plasma or a therapeutic agent; various dialysis apparatus; pumps and the like. Additionally, this term may refer to any element that is intended to cause fluid to flow out from the patient such as in case of a dialysis system, that removes and reinserts blood from and into the patient respectively.
The term “patient fluid administration member” refers to any element which is connected on one side (its proximal side) to the manifold hub, and on the other side (its distal side) either directly or indirectly to an entry member, which is inserted to the patient's vascular system, or to any other orifice or vessel of the patient. Examples of “patient fluid administration members” include individual tubes, which may be single or multi lumen, or a plurality of tubes, singular or multi lumen, that may be attached to each other in a bus type configuration. These tubes, in turn, can be connected to, for example, a needle, a catheter which is fully or partially inside the patient's vascular system or other vessel, a cannula and the like. The manifold may also be connected to a multi lumen tube which is within the body of the patient, the tube forming an extension-less catheter. It should be noted that the term “patient fluid administration member” is not solely intended to denote a member capable of administering fluid into the patient but also to a member capable of removing blood from the patient to the peripheral element, for example, in dialysis.
The term “fluid administration system” as used herein, refers to a system for transferring fluid, comprising at least a manifold hub, at least one fluid peripheral element and a fluid administration member, as described below.
The term “fluid administration external infusion manifold”, as used herein below, as well as a variety of particular embodiments, shall be all referred to herein in the general term “manifold” or “manifold hub”. A manifold generally comprises a plurality of inlets, having a single outlet. A manifold hub, to which the present invention relates, is generally a device for connecting a plurality of inlet ports to at least one external object. In particular, the manifold hub may comprise an identical number of inlets as outlets, or, alternatively, the number of inlets may be different than that of outlets. Additionally, for simplicity's sake, although some embodiments as described herein relate to a plurality of isolated lumens joined by a single port at one end, i.e. a hub, and others, to a plurality of isolated lumens that are not joined at one end, the term “manifold hub” is used throughout.
The terms “upper” and “lower”, in particular, when referring to the intermediate gasket layers of the present invention, as described herein, are meant to describe different layers of the housing of the present invention, relative to each other, and not to imply that both layers need always be present. In other words, when only the upper layer, or only the lower layer may be present, the layers are nevertheless referred to as “upper” or “lower”, respectively.
The terms “sealing” and “isolated” as used herein, particularly when describing the relationship between lumens, refer to preventing at least fluid communication between lumens or flow channels.
The term “fluid”, as used herein, shall refer to any liquid, solvent, diluent, saline, water, liquefied medicament as well as to any biofluid, human or other, allowed to flow out of or withdrawn from the body of a patient, including blood and blood products, plasma, nutrients and medicaments.
The term “standard” and the term “conventional” when referring to a female luer (FL) activated valve (also referred to herein as, “luer activated connector”) or when referring to a male luer (ML) or Male Luerlock (MLL), generally relates to any normal, ISO, ANSI and/or universal luer activated valve type connection known in the art. High flow connectors are adapted to provide a flow of fluids in a flux higher than that allowed by the aforementioned conventional FL. A high flow connector is thus characterized by having a larger bore, and its connecting coupler is larger than a conventional luer activated connector. The term ‘connector having a minimal dead space’ is defined as a connector characterized by a small bore, and its connecting coupler is smaller than that of a conventional luer connector. The standard luer activated connectors as described herein preferably comprise a standard luer lock feature for the standard connector locking system and/or with any other locking feature for the high and low connector locking system.
Fluid administration external infusion manifolds are widely used for administering therapeutic fluids, into the body of a patient, from a plurality of fluid reservoirs. Currently available manifolds do not provide simultaneous infusion of a plurality of fluids in a manner such that fluids do not mix as they pass through the manifold.
Typically, a manifold, in particular, a manifold connected to a catheter device, comprises a single lumen having an outlet port, through which a fluid is transferred, to a patient. The single lumen has multiple inlet ports, each of which can be connected to a separate fluid reservoir, and valves, such as stopcock valves, for closing and opening the entry of fluid to the lumen. However, since all fluids flow through the single, common lumen, and out the same outlet port, when using the manifold, the working fluid mixes with fluid residue contained within the lumen from a previous use, which can result in undesirable interaction between the fluids.
This problem is overcome by flushing the lumen with a neutral fluid, such as saline, before administering a second fluid, in order to replace the dead space to the manifold.
It is evident that this method of cleaning the manifold from excess fluid is undesirable, as unnecessary administration of a “neutral” fluid is required.
Furthermore, prior art administration systems require much handling by the medical personnel (e.g. nurses), including rinsing, flushing and opening and closing of valves and/or stopcocks in order to remove the residue fluid. This further increases the risk of undesirable therapeutic fluid mixing.
Additional requirements of fluid administration systems include priming the manifold prior to use, wherein the entire manifold housing is primed with a predetermined solution in order to prepare the manifold for use by ensuring the lumen is free from air bubbles.
In prior art manifolds, individual connectors, such as luer activated connectors, are individually situated at each manifold inlet port for securing each of the plurality of fluid reservoirs to the ports.
A device for simultaneously administering two or more fluids to a patient, without allowing the fluids to mix, is well known, for use with catheters. The hub of a multi lumen catheter is connected in its proximal end to isolated lumen extensions that are connected to fluid reservoirs when fluid is required to be administered to the patient, and may be disconnected therefrom when not requiring fluid administration. For prior art catheters, the patient must cope with the awkwardness associated with tubes exiting the body. For instance, multi lumen catheter hub designs cause irritation when mounting in place and cause the patient discomfort when dressing and undressing. These drawbacks are particularly undesirable during long term treatments. It would therefore be beneficial to have a catheter that does not require tubes to exit the patient's body when not in use.